OneTouch UltraEasy Page 32 User Manual Download

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ERROR MESSAGES AND DETAILS ABOUT YOUR SYSTEM

LifeScan self-test blood glucose monitoring devices conform to the following EU Directives:

IVDD (98/79/EC):

Blood Glucose Meter, Test Strips, and Control Solution.

MDD (93/42/EEC):

Lancets

Blood Sampler

LifeScan Europe

Division of Cilag GmbH

International

6300 Zug

Switzerland

Electrical and safety standards

The meter has been tested for immunity to Level 4 electrostatic discharge as specified in IEC 61000-4-2. This meter has been tested for immunity

to radio frequency interference over the frequency range 80 MHz to 2.5 GHz at 3 V/m as specified in IEC 61000-4-3. Degree of protection rating:

Minimum of IP2X. This meter complies with CISPR 11:2003, Class B (Radiated Only). Emissions of the energy used are low and are not likely to

cause interference in nearby electronic equipment.

Guarantee

LifeScan guarantees that the OneTouch® UltraEasy® Meter will be free of defects in material and workmanship for three years, valid from the date

of purchase. The guarantee extends only to the original purchaser and is not transferable.

The system described herein is covered by one or more of the following U.S. patents: 6,284,125, and D546,216. Use of the monitoring device

included herein is protected under one or more of the following U.S. patents: 7,250,105, 6,413,410, 6,733,655, 7,468,125. Purchase of this device

does not act to grant a use license under these patents. Such a license is granted only when the device is used with OneTouch® Ultra® Test Strips.

No test strip supplier other than LifeScan is authorized to grant such a license. The accuracy of results generated with LifeScan meters using test

strips manufactured by anyone other than LifeScan has not been evaluated by LifeScan.

Notes

0120

Summary of Contents for UltraEasy

Page 1: ...AW 06629402C Rev date 07 2012 USER GUIDE Blood Glucose Monitoring System ...

Page 2: ...m 24 Call OneTouch Customer Care UK 0800 121200 Ireland 1800 535676 Or Visit us at www LifeScan co uk If you cannot reach OneTouch Customer Care contact your healthcare professional for advice LifeScan Europe Division of Cilag GmbH International 6300 Zug Switzerland 2009 LifeScan Inc Distributed by LifeScan UK a Division of Ortho Clinical Diagnostics Johnson Johnson 50 100 Holmers FarmWay HighWyco...

Page 3: ...d for the quantitative measurement of glucose sugar in fresh capillary whole blood The OneTouch UltraEasy System is intended for self testing outside the body invitro diagnostic use by people with diabetes at home and by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control It should not be used for the diagnosis of diabetes or for testing newbor...

Page 4: ...ustomer Care 0800 121200 UK or 1800 535676 Ireland Available separately e OneTouch Ultra Test Strips f OneTouch Ultra Control Solution g Clear Cap for AST testing For availability of control solution call OneTouch Customer Care 0800 121 200 UK or 1800 535 676 Ireland e f g WARNING Keep the meter and testing supplies away from young children Small items such as the battery door battery test strips ...

Page 5: ...splay mmol L is the pre set unit of measure Up and down buttons Turns the meter on or off Select or change information Test port Insert test strip here to turn meter on for testing TEST STRIP Edge to apply sample Confirmation window Contact bars Insert into test port ...

Page 6: ...should appear briefly on the start up test screen to tell you that the meter is working properly To check that all display segments are working as soon as the start up test screen appears press and hold to keep the start up test screen display on Release to proceed to the next step If the meter does not power on try changing the meter battery See Replacingthebattery in Section 6 Turning your meter...

Page 7: ...ay for five seconds The hour will now start flashing NOTE If a setting does not need to be updated simply wait five seconds The meter display will automatically advance to the next setting Set the hour With the hour flashing on the display press and release or to go forward or backward one hour To move faster hold the or buttons down When the correct hour appears on the display wait five seconds Y...

Page 8: ...tart flashing 5 Set the month Press or to change the month When you have the correct month on the display wait five seconds to move to the next setting The day will now start flashing 6 Set the day Press or to change the day When you have the correct day on the display wait five seconds to move to the next screen Your time and date settings will be displayed for five seconds After the five seconds...

Page 9: ...ing it from the vial Hold the meter as shown and insert the test strip into the test port Make sure the three contact bars are facing you Push the test strip in as far as it will go Do Not bend the test strip CAUTION The test strip vial contains drying agents that are harmful if inhaled or swallowed and may cause skin or eye irritation CAUTION Ifyoucannottestduetoaproblemwithyourtestingsupplies co...

Page 10: ...ash on the display for three seconds and then stay constant for three seconds The display will advance to the screen with the flashing blood drop icon R If the codes already match wait three seconds The display will advance to the screen with the flashing blood drop icon R The meter is now ready to perform a blood glucose test NOTE If the screen with the flashing blood drop icon R appears before y...

Page 11: ... use only Keep your meter and lancing device clean See Caringforyour system in Section 6 NOTE If you do not have a lancing device please refer to the instructions that came with your lancing device Theblue orblack capandclearcaparealsousedfordepthadjustment Getting a blood sample Overview of the Lancing Device Cockingcontrol Blue or black cap for fingertip sampling Sterile lancet Lancet point Prot...

Page 12: ...e Shallower punctures work for children and most adults Deeper punctures work well for people with thick or callused skin Twist the blue or black cap until the correct setting appears NOTE A shallower puncture may be less painful Try a shallower setting first and increase the depth until you find the one deep enough to get a large enough drop of blood approximate size Cock the lancing device Slide...

Page 13: ...on Remember Consult with your healthcare professional before using your forearm or palm for testing Choose a different puncture site each time you test Repeated punctures in the same spot may cause soreness and calluses If bruising occurs at an alternate site or you have difficulty getting a sample consider sampling from a fingertip instead You may want to review the choice of sites with your heal...

Page 14: ...d flow for a good sample Then press the release button while continuing to apply pressure Keep holding the lancing device against your skin until a round drop of blood forms under the cap Forearmsampling Choose a fleshy area of the forearm away from bone visible veins and hair Sometimes there is less blood flow to the forearm than to the fingertips To help you get a large enough drop of blood you ...

Page 15: ... the meter When applying a drop of blood from your forearm or palm keep your palm or forearm steady and bring the top edge of the test strip to the drop of blood with your other hand Fingertip Palm Forearm When sampling blood from your forearm or palm make sure the drop of blood is large enough approximate size before you release pressure and remove the lancing device Remove the lancing device Car...

Page 16: ...not fill the confirmation window completely See Understandingerrorandothermessages in Section 7 Discard the test strip and re start the test process NOTE Do Not smear or scrape the drop of blood with the test strip Do Not apply more blood to the test strip after you have moved the drop of blood away Do Not move the test strip in the meter during a test Apply the sample Line up the test strip with ...

Page 17: ...nd time of the test Blood glucose results are automatically stored in the meter s memory CAUTION If you test at the low end of the operating range 6 44 C and your glucose is high over 10 0 mmol L the reading on your meter may be lower than your actual glucose In this situation repeat the test in a warmer environment with a new test strip as soon as possible WARNING If mmol L does not appear with t...

Page 18: ...cted glucose results If you continue to get unexpected results check your system with control solution See Section 5 Control solution testing If you are experiencing symptoms that are not consistent with your blood glucose results and you have followed all instructions in this User Guide call your healthcare professional Never ignore symptoms or make significant changes to your diabetes control pr...

Page 19: ...and release to turn it on After the start up test screen your most recent test result will appear on the display M also appears to indicate memory mode If you have just completed a test leave the test strip in the meter and press to enter the memory mode Your most recent blood glucose test result appears along with M Press to move to the previous result stored in the meter Then press or to move fo...

Page 20: ...To avoid a possible shock Do Not insert a test strip when the meter is connected to a computer with the OneTouch Interface Cable Downloading results to a computer You can use your meter with OneTouch Diabetes Management Software DMS for storing your records and to help you spot patterns for planning meals exercise and medication OneTouch DMS puts information downloaded from the meter into charts a...

Page 21: ... the screen with the flashing blood drop icon R If the codes already match wait three seconds The display will advance to the screen with the flashing blood drop icon R Mark the test as a control solution test IMPORTANT Mark all control solution tests with CtL This will stop them from being stored as blood glucose results Control solution results marked with CtL are not stored in the meter s memor...

Page 22: ...to 1 Your result will then appear on the display along with CtL and the unit of measurement Check if the result is in range Compare the result displayed on the meter to the control solution range printed on the test strip vial Each vial of test strips may have a different control solution range If the results you get are not within this range the meter and test strips may not be working properly R...

Page 23: ...e of the meter display to indicate low battery When there is enough power for a minimum of 100 more tests the battery icon will appear After each test and when reviewing past results the battery icon will now flash to remind you to change the battery as soon as possible When the battery icon is flashing by itself on the display you cannot perform a test You must install a new battery before using ...

Page 24: ...he battery turn the meter on by pressing and holding the button for five seconds to access the set up mode The start up test screen will be briefly displayed then the date and time will appear in the top right corner of the display Check that the time and date are set correctly If they are not use the and buttons to re set the meter before testing See Settingthetimeanddate in Section 2 NOTE Removi...

Page 25: ...al maintenance Storing your system Store your meter test strips and control solution in your carrying case after each use Store each item in a cool dry place below 30 C but Do Not refrigerate Keep all items away from direct sunlight and heat Tightly close the cap on the test strip vial and or control solution vial immediately after use to avoid contamination or damage Store test strips only in the...

Page 26: ... cleaning solution on the meter or immerse it in any liquid Cleaning your lancing device and clear cap To clean these items wipe them with a soft cloth dampened with water and mild detergent Do Not immerse the lancing device in any liquid To disinfect these items prepare a solution of one part household bleach to nine parts water Wipe the lancing device with a soft cloth dampened with this solutio...

Page 27: ... this message could be due to a test error it is safer to treat first and then do another test You may have a very high blood glucose level severe hyperglycaemia over 33 3 mmol L Re check your glucose level If the result is HI again obtain and follow instructions from your healthcare professional without delay The meter has detected that the temperature is above the system operating range Do Not p...

Page 28: ...OneTouch Customer Care 0800 121200 UK or 1800 535676 Ireland Error message could be caused either by a used test strip or a problem with the meter Repeat the test with a new test strip see Section 3 Testing your blood glucose If this message continues to appear contact OneTouch CustomerCare0800121200 UK or 1800 535676 Ireland Error message indicates that the blood or control solution sample was ap...

Page 29: ...nvironment near the low end of the system s operating temperature range 6 44 C or There may be a problem with the test strip For example it may have been damaged or moved during testing or The sample was improperly applied or There may be a problem with the meter Ifyoutestedinacoolenvironment repeat thetestinawarmerenvironmentwitha newteststrip seeSection3 Testingyour bloodglucose Ifthiserrormessa...

Page 30: ...ou get a high glucose result i e greater than 10 0 mmol L In this situation repeat the test in a warmer environment with a new test strip as soon as possible For accuracy and precision data and for important information on limitations see the insert that comes with your test strips To maximize your chances of an accurate comparison between meter and laboratory results follow a few basic guidelines...

Page 31: ...t came with your meter and testing supplies Direct current Low battery SN Serial Number LOT Lot number IVD In vitro diagnostic medical device Expiration date Sterilized by irradiation Storage temperature limits Consult instructions for use n Contains sufficient for n tests 2 Do not reuse Manufacturer Separate collection of batteries Recycle ...

Page 32: ...kely to cause interference in nearby electronic equipment Guarantee LifeScan guarantees that the OneTouch UltraEasy Meter will be free of defects in material and workmanship for three years valid from the date of purchase The guarantee extends only to the original purchaser and is not transferable The system described herein is covered by one or more of the following U S patents 6 284 125 and D546...

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